KR200498176Y1 - Medical devices for controlling intestinal excretion, uses and methods - Google Patents

Abstract

The present invention relates to a compact medical device for controlling the discharge of excrement from a patient's external fistula and a control method thereof, including a flange including a vent hole and a vent cover for discharging gaseous excretion, and a flange for attachment to the patient's body. characterized by comprising an adhesive layer coupled to the flange, a cover configured to be displaceable and connected to the flange for closing and opening the device, and an opening configured to surround the fistula for drainage of feces.

Description

Medical devices for controlling intestinal excretion, uses and methods

[0001] The present invention relates to a medical device for controlling the discharge of intestinal contents in colostomy patients, and is intended for all patients who have undergone colostomy surgery.

[0002] Colostomy surgery consists of a surgical procedure in which one cross-section of the colon is operated on and the other side is anastomosed to the abdominal wall, with the anal area sutured and closed.

[0003] Patients who have had colostomy surgery may need to use a colostomy bag for waste collection, which may be temporary or “permanent.” During this process, most patients experience changes in their personal, private, social and professional aspects. Patients who have undergone colostomy surgery lose control over intestinal gas discharge and defecation and suffer from many physical and psychological problems and limitations, the severity of which varies depending on the patient's resilience.

[0004] The above problem is significantly increasing worldwide. According to the United Ostomy Associations of America, in the United States alone, there are more than 750,000 patients with at least one type of ostomy - 36.1% (270,000) for colostomy surgery and 32.3% (242,000) for ileostomy surgery. Additionally, more than 100,000 new ostomies are performed each year in the United States.

[0005] The number of patients who received ostomy surgery in Portugal is estimated at 10,000-12,000, while in the European Union (EU) it is approximately 700,000 (RTP, 2015) (Eucomed- Medical Technology, 2012a) (Eucomed- Medical Technology, 2012b) That's about it. The above study cannot be considered as an accurate indicator of the number of colostomy patients in Portugal or internationally, but it shows an explanatory aspect of the relevance of health problems.

[0006] Excrement collection devices play a role in managing ‘excrement collection’, which is a major problem in ostomies. Therefore, much effort has been made to partially improve product features such as gas filters, fixtures and other detailed parts. Nonetheless, the overall concept remained the same, with only minor changes. In general, there have been remarkable advancements in medical devices along with available technology over the past few years. However, despite scientific efforts to provide alternatives to the colostomy sac, such as artificial sphincters and blocking devices, colostomy-related medical devices have not yet found effective alternatives.

[0007] United States Patent Publication US8998867B2 discloses an ostomy device consisting of an implant that, when in use, is placed inside the human body near the site of the fistula (stoma). When used, the excretion device serves to allow intestinal waste to exit the human body. It also includes means for operably connecting to the implant in use and enabling its removal from the site of the fistula. The discharge device is held at the fistula site by magnetic force between the implant and the discharge device.

[0008] As mentioned in the above US Patent Publication US8998867B2, the device aims to eliminate the ostomy bag. However, it is much more complicated because it requires surgery to reliably implant the device inside the patient's body, which can lead to several complications, including implant rejection and discomfort. To date, this product is not for sale.

[0009] United States Patent Publication US2018333290A1 is a design for the stable emptying of bodily waste from a reusable and drainable medical device, such as an ostomy bag.

[0010] International Patent Publication WO201258388A1 relates to a controlled excretion ostomy device, comprising: a pouch having a first wall and a second wall, the first wall comprising a fistula opening; non-entrant stoma seal; an internal coupling member coupled to support the fistula seal to maintain the fistula seal in an operative position relative to the fistula opening; an external coupling member for supporting the device around the internal coupling member; A cover of flexible shock absorbing material covering at least a portion of a second wall opposite the fistula opening, the cover including a retainer for retaining the lower portion of the pouch in a collapsed state.

[0011] United States Patent Publication US20120109086A1 relates in particular to a controlled discharge ostomy device with a stoma occluding seal.

[0012] The above publication is introduced to explain the technical issues addressed in this specification.

[0013] The present invention relates to a medical device for controlling the discharge of intestinal contents in colostomy patients, and is intended for all patients who have undergone colostomy surgery. Patients can instantly control intestinal gas and excrement without having to show the ostomy bag anymore, and can avoid uncomfortable noises and smells by choosing the most appropriate location.

[0014] Considering the extent of the problem affecting millions of people around the world, we went one step further and completed the present design by improving the device for controlling the discharge of intestinal contents. This design will significantly improve the patient's quality of life and self-esteem.

[0015] The present design is a non-surgical device that can not only greatly improve the user's quality of life, but also grants greater autonomy and makes it possible to maintain freedom and intimacy.

[0016] In some embodiments of the present invention, the present invention is an improvement over other available commercially available products in that it is reusable, fully washable, and/or sterilizable, allowing for long-term use.

[0017] In some embodiments of the present invention, the present invention relates to a compact medical device for controlling the discharge of fecal matter from an external fistula of a patient, comprising: a flange; Here, the flange includes a vent hole and a vent cover for discharging gaseous waste; an adhesive layer bonded to the flange for attachment to the patient's body; a displaceable cover for closing and opening the device; wherein the displaceable cover is configured to be connected to the flange; It includes an opening configured to surround the fistula for drainage of feces.

[0018] In some embodiments of the present invention, the medical device includes a pressure sensor for measuring the pressure of excrement in the displaceable cover; alarm system; and a data processor capable of activating an alarm system when the pressure is above a predetermined threshold.

[0019] In some embodiments of the invention, the pressure threshold is at least 120 mmHg, preferably at least 5-90 mmHg, more preferably at least 15-80 mmHg, even more preferably at least 20-60 mmHg.

[0020] In some embodiments of the present invention, the medical device further includes a second flange. Here the flanges are connectable or connected.

[0021] In some embodiments of the present invention, the pressure limit value is adjustable according to patient characteristics.

[0022] In some embodiments of the present invention, the medical device includes a collapsible container.

[0023] In some embodiments of the present invention, the collapsible container is attachable or attached to the second flange.

[0024] In some embodiments of the present invention, the collapsible container includes a fistula contact surface configured to be positioned over the fistula.

[0025] In some embodiments of the present invention, the fistula contact surface is concavely disposed to connect to the fistula.

[0026] In some embodiments of the present invention, the fistula contact surface is, among others, sponge, gauze, cotton, or a combination thereof.

[0027] In some embodiments of the present invention, the collapsible container is a colostomy bag, an ileostomy bag, a urostomy bag, a trachea bag, or a combination thereof.

[0028] In some embodiments of the present invention, the colostomy bag is a compact colostomy bag, a compact ileostomy bag, a compact urostomy bag, a compact tracheal bag, or a combination thereof.

[0029] In some embodiments of the present invention, the medical device further includes a temperature sensor, a gas sensor, or a combination thereof.

[0030] In some embodiments of the present invention, the displaceable cover is a vertically displaceable cover. In particular, the displaceable cover is removable.

[0031] In some embodiments of the present invention, the displaceable cover is rotatably or magnetically attached to the first or second flange.

[0032] In some embodiments of the present invention, the adhesive layer is rotatably or magnetically attached to the flange for fixation to the patient's body.

[0033] In some embodiments of the present invention, the adhesive layer is adhesively attached to the flange to secure it to the patient's body.

[0034] In some embodiments of the present invention, the flange is rotatably or magnetically coupled to at least one flange.

[0035] In some embodiments of the present invention, the first flange is coupled to the second flange with an adhesive.

[0036] In some embodiments of the present invention, the collapsible container is disposable and/or biodegradable.

[0037] In some embodiments of the present invention, the vent hole and the vent cover are disposed between the flanges so that the pressure of the excrement is relieved by opening the vent cover.

[0038] In some embodiments of the present invention, the vent hole and vent cover include an odor filter, an elastomeric barrier, or a combination thereof.

[0039] In some embodiments of the present invention, the elastomeric barrier is sealed.

[0040] In some embodiments of the present invention, the alarm system further includes a power source for supplying power to the alarm system. In particular, the power source is a battery.

[0041] In some embodiments of the present invention, the battery is charged by induction, a USB port, using the patient's movement to extract the charge, the patient's body temperature, or a combination thereof.

[0042] In some embodiments of the present invention, the alarm system includes an alarm.

[0043] In some embodiments of the present invention, the alarm further includes a visual alarm, a vibration alarm, an acoustic alarm, a smartphone alarm, a smart watch alarm, a tablet alarm, or a combination thereof or others.

[0044] In some embodiments of the present invention, the device further includes a Wi-Fi system, a Bluetooth system, or a combination thereof, or among others.

[0045] In some embodiments of the present invention, the medical device is watertight.

[0046] In some embodiments of the present invention, the excretions are bodily fluids, especially intestinal contents, more particularly solid, liquid or gaseous intestinal contents.

[0047] In some embodiments of the present invention, all components of the medical device are suitable polymers.

[0048] Another aspect of the present invention relates to an ostomy bag containing the medical device described in any of the embodiments. In particular, the ostomy bag is a colostomy bag, an ileostomy bag, a urostomy bag, a tracheal bag, or a combination thereof.

[0049] Another aspect of the present invention relates to a method of controlling the discharge of fecal matter from an external fistula of a patient using the medical device described in any of the embodiments:

The device of the present invention is fixed to the patient's body, measures the pressure of the patient's intestinal contents, and uses a data processor to process the capture pressure of the human intestinal contents to activate an alarm system when the pressure is above a threshold value. . Preferably, the patient can disable the alarm system.

[0050] The attached drawings present preferred embodiments for illustrating the present invention and should not be construed as limiting the scope of the present invention.
[0051] Figure 1 is a schematic diagram of a completed medical device embodiment for controlling the discharge of intestinal contents in patients undergoing colostomy surgery.
[0052] Figure 2 is a perspective view of the device placed on the user's body in a closed state.
[0053] Figure 3 is a perspective view of the device with the top cover opening and compressed collection bag placed on a user's body.
[0054] Figure 4 is a perspective view of the device with the cover opening and inflated collection bag positioned on the body of a user.
[0055] Figure 5 is a frontal schematic diagram showing the completed device for controlling the discharge of intestinal contents in patients undergoing colostomy surgery.
[0056] Figure 6 is a schematic diagram of a device for controlling the discharge of intestinal contents in a patient undergoing colostomy surgery.
[0057] Figure 7 is a schematic diagram of a detailed operating method.
[0058] Figure 8 is a side view of the device of the present invention.
[0059] Figure 9 is a schematic diagram of the main components of the device in an alternative form.
[0060] Figure 10 is a top view of the device in an alternative form.
[0061] Figure 11 is a perspective view of the device in an alternative form.
[0062] Figure 12 is a perspective view of the device in an alternative form.

[0063] The present invention relates to a compact medical device and a control method for controlling the discharge of excrement from a patient's external fistula, which includes a flange including a vent hole and a vent cover for discharging gaseous excretion, and It includes an adhesive layer coupled to the flange for attachment, a cover configured to be displaceable and connected to the flange for closing and opening the device, and an opening configured to surround the fistula for drainage of feces.

[0064] The attached drawings present preferred embodiments to illustrate the present invention and should not be construed as limiting the scope of the present invention.

[0065] In some embodiments of the present invention, the device of the present invention is completely waterproof, washable, and non-invasive. It consists of an exterior part (13) of minimalist design and a front opening through a displaceable cover (4).

[0066] In some embodiments of the invention, the device of the invention is fixed to the body through an adhesive layer (6), such as those already existing on the market, to prevent feces, gases, and odors from being released in an uncontrolled manner. do. The device is fixed to the abdominal wall and does not require additional surgery.

[0067] In some embodiments of the present invention, inside the device of the present invention there is a disposable part (13) consisting of a colostomy bag (5) fully compressed in a system similar to an “airbag”. Between this part and the fistula, there is a vent cover (7) with an odor neutralizer (8) for controlling gas emissions. Between the displaceable cover (4) and the colostomy bag (5) system there is a pressure sensor (9). When the intestinal contents begin to exert a predetermined pressure at a safe and appropriate pressure value, the sensor 9 inside the device triggers an electronic alarm 12 (vibration, sound or bright signal), for example synchronized with a smartphone app. Activate to alert the patient of the need to go to an appropriate location to expel intestinal contents.

[0068] In some embodiments of the present invention, relief of intestinal pressure by stool or gas can be distinguished in two different ways depending on the cause of actuation of the sensor 9.

[0069] In some embodiments of the present invention, when gas is filled inside the device 13 of the present invention, it is discharged through the operation of the vent cover 7.

[0070] In some embodiments of the present invention, if there is feces inside the device of the present invention, the user simply opens the displaceable cover (4), and the pressure change automatically causes the collection bag (5) inside the device. is properly compressed and expanded and filled with feces. Once discharge is complete, the user removes the biodegradable bag (5) and replaces it with a new one after hygiene management.

[0071] In some embodiments of the present invention, the device of the present invention is correctly secured when it engages the fastening device by engaging and rotating, followed by a “click” sound. The lock will be released only by rotating the entire part (second flange (2) and first flange (1)) while simultaneously applying pressure manually at one point to avoid inadvertent loosening. When a predetermined pressure of the intestinal contents is reached, the pressure sensor 9 activates the alarm system 12 to send a signal, vibration, sound, brightness, and/or a smart phone app to prompt the user to empty the collection pouch. Informs you that you need to go to a location.

[0072] In some embodiments of the present invention, the user must manually operate the vent valve to remove the gas. This action relieves the pressure and disables the alarm system 12. If the alarm does not work, the user must manually open the top cover (4), and the pressure is naturally relieved and the ostomy bag (5) containing the intestinal contents is inflated. Next, the user removes the already full collection bag (5), puts in a new bag (5) after hygiene management, and closes the displaceable cover (4).

[0073] In some embodiments of the subject matter, the subject matter device 13 is appropriately sealed to prevent the electrical and electronic systems 10, 11, and 12 from being damaged during use. The device's quick-engagement devices (second flange and first flange) are not only user-friendly but also water-proof to avoid any untoward discomfort to the user.

[0074] In some embodiments of the invention, the device of the invention is supplied with electrical energy by a battery (10) that is easily recharged by the user through access at the device (13).

[0075] In some embodiments of the present invention, the present invention is capable of complete removal, cleaning, and sterilization, allowing the user to clean it whenever necessary.

[0076] Throughout this specification, the term “comprising” refers to a referenced feature, entity, step, or component, but does not exclude one or more other features, entities, steps, components, or groups thereof. .

[0077] Unless otherwise specified herein, those skilled in the art will recognize that the specific order of steps described is merely illustrative and that the order may be changed within the scope of the present invention. Accordingly, unless otherwise stated, the steps described may proceed in any convenient or preferred order, if possible.

[0078] This specification should not be limited to the described embodiments, and those skilled in the art will recognize that many modifications are possible. The above embodiments can be combined. The following claims further set forth specific embodiments of the present invention.

Claims (34)

A flange (1) including a vent hole and a vent cover for discharging gaseous wastes;
an adhesive layer (6) coupled to the flange (1) for attachment to the patient's body;
A cover (4) configured to be connected to the flange (1) and displaceable for opening and closing the device; and
An opening formed to surround the fistula for drainage of feces;
A compact medical device comprising:
second flange (2);
one pressure sensor (9) for measuring the pressure of human waste in the displaceable cover (4);
One alarm system (12); and
a data processor capable of activating the alarm system (12) when the pressure is above a predetermined threshold;
It further includes,
The flanges (1, 2) are connected or connectable,
The limit value of the pressure is 5-90 mmHg,
A medical device for controlling the discharge of feces from a patient's external fistula, characterized in that.
2. Medical device according to claim 1, wherein the pressure varies between 15-80 mmHg.
The medical device according to claim 1, wherein the limit value of the pressure is adjustable according to patient characteristics.
2. Medical device according to claim 1, characterized in that the medical device comprises a collapsible container (5).
5. Medical device according to claim 4, characterized in that the collapsible container (5) is attachable to the second flange (2).
5. Medical device according to claim 4, characterized in that the collapsible container (5) is attached to the second flange (2).
5. Medical device according to claim 4, characterized in that the collapsible container (5) comprises a fistula contact surface adapted to be positioned in the fistula.
The medical device according to claim 7, wherein the fistula contact surface is concavely disposed to connect to the fistula.
8. The medical device of claim 7, wherein the fistula contact surface is sponge, gauze, cotton, a suitable polymer, or a combination thereof.
5. Medical device according to claim 4, wherein the collapsible container (5) is a colostomy bag, an ileostomy bag, a urostomy bag, a trachea bag or a combination thereof.
The medical device of claim 10, wherein the colostomy bag is a compact colostomy bag, a compact ileostomy bag, a compact urostomy bag, a compact tracheal bag, or a combination thereof.
The medical device of claim 1, further comprising a temperature sensor, a gas sensor, or a combination thereof.
The medical device of claim 1, wherein the displaceable cover is a vertically displaceable cover.
2. The medical device of claim 1, wherein the displaceable cover is a removable cover.
2. Medical device according to claim 1, characterized in that the displaceable cover is rotatably or magnetically attached to the flange (1) or the second flange (2).
2. Medical device according to claim 1, characterized in that the adhesive layer is rotatably or magnetically attached to the flange (1) for fixation to the patient's body.
2. Medical device according to claim 1, characterized in that the adhesive layer attaches the flange (1) with adhesive for fixation to the body of the patient.
2. Medical device according to claim 1, wherein the flange (1) is rotatably or magnetically coupled to another flange.
2. Medical device according to claim 1, characterized in that the flange (1) is joined to the second flange (2) with adhesive.
5. Medical device according to claim 4, characterized in that the collapsible container (5) is disposable or biodegradable.
The medical device according to claim 1, wherein the vent hole and the vent cover are disposed within the flange (1) so that the pressure of the excrement is relieved by opening the vent cover.
The medical device of claim 1, wherein the vent hole and the vent cover include an odor filter, an elastomeric barrier, or a combination thereof.
23. The medical device of claim 22, wherein the elastomer barrier is sealed.
The medical device according to claim 1, wherein the alarm system further includes a power source for supplying power to the alarm system, and the power source is a battery.
2. The medical device of claim 1, wherein the alarm system includes an alarm.
The medical device of claim 1, wherein the medical device is watertight.
The medical device according to claim 1, wherein the excretion is intestinal contents of body fluid, solid, liquid or gas.
The medical device according to claim 1, wherein all components of the medical device are made of polymer material.
An ostomy bag comprising a medical device according to any one of claims 1 to 28.
The ostomy bag according to claim 29, wherein the ostomy bag is a colostomy bag, an ileostomy bag, a urostomy bag, a tracheal bag, or a combination thereof. delete delete delete delete